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转移性前列腺癌老年男性的预防性支持性护理干预 (TOPCOP3):试点随机对照试验和过程评估
Shabbir M H Alibhai1, Martine Puts2, Rana Jin1
1Department of Medicine, University Health Network, Toronto, Ontario, Canada.
Journal of geriatric oncology
|March 23, 2024
概括
这项研究调查了老年病的评估和管理 (GA+M) 和远程症状监测 (RSM) 以减少毒性和改善老年人转移性前列腺癌的生命质量,在色素受体轴向治疗 (ARATs). 结果将为支持性护理干预措施的更大规模试验提供信息.
科学领域:
- 老年瘤学 老年瘤学
- 医学瘤学 医学瘤学
- 临床试验 临床试验
背景情况:
- 转移性前列腺癌 (mPC) 管理涉及基受体轴向疗法 (ARATs),在老年人中具有显著的毒性.
- 老年人的评估和管理 (GA+M) 和远程症状监测 (RSM) 提高了化疗耐受性,但尚未对ARAT进行研究.
研究的目的:
- 评估GA+M和RSM单独或组合的疗效,以改善接受ARAT的mPC的老年人治疗耐受性和生活质量 (QOL).
主要方法:
- 一个多中心的,因数试验性临床试验 (TOPCOP3) 有四个臂:GA+M,RSM,联合GA+M和RSM,以及通常的护理.
- 招募了168名患者,在基线和1.5,3,4.5和6个月的评估.
- 共同初级结局:3-5级毒性和QOL (EuroQol5维度). 二次结果:疲劳,失眠,抑郁. 过程评估:可行性,真实性,可接受性,障碍,促进者.
主要成果:
- 目前正在进行数据收集,以评估GA+M和RSM对QOL的影响以及老年人mPC对ARAT的毒性.
- 该研究旨在提供用于设计最终III期随机对照试验的数据.
结论:
- 这项试点研究将扩大癌症老年人的支持性护理干预措施.
- 结果将为未来对mPC管理的大规模临床试验的设计和实施提供信息.
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